Blood Pressure Monitor Calibration

ABSTRACT

A blood pressure monitor, particularly of the type having an inflatable cuff communicating with a pressure sensor and suitable for home use, may be calibrated by applying a sealed canister containing gas at a known pressure to a port so as to apply the known pressure to the pressure sensor, and comparing a pressure signal from the pressure sensor with the known pressure so as to determine a calibration error of the sensor and/or adjust the calibration of the sensor, e.g. by electronically adjusting the sensor. Several canisters may be used to calibrate the sensor across a range of pressures, each canister having a different known pressure. Each canister is preferably ruptured when attached to the port and is not re-usable, and may comprise an identifier such as an electronically readable identifier which is stored in a memory in association with the value of the known pressure within the canister. Temperature sensing means may be provided whereby the pressure reading is adjusted to compensate for temperature, e.g. of the gas released from the canister. The monitor may comprise means for sensing mechanical shock and alerting a user or remote monitoring personnel to provide an indication that recalibration is required.

CROSS REFERENCE TO RELATED APPLICATIONS

This U.S. patent application is a continuation of, and claims priorityunder 35 U.S.C. §120 from, U.S. patent application Ser. No. 13/811,821,filed on Jan. 28, 2013, which is the National Stage of InternationalApplication No. PCT/GB2011/051411 filed Jul. 25, 2011. The disclosuresof the prior applications are considered part of the disclosure of thisapplication and are hereby incorporated by reference in theirentireties.

TECHNICAL FIELD

The present disclosure relates to blood pressure monitor calibration, inparticular the calibration of a blood pressure monitor using a knownpressure.

BACKGROUND

Cardiovascular disease (CVD) is responsible for one third of globaldeaths and is a leading and increasing contributor to the global diseaseburden. Hypertension is already a highly prevalent risk factor for CVDthroughout the industrialised world, and is becoming an increasinglycommon health problem in many developing countries, particularly inurban societies.

The accurate measurement of blood pressure is the sine qua non forsuccessful management of hypertension. Blood pressure is usuallymeasured using a sphygmomanometer or blood pressure monitor. One of themain factors influencing the accuracy of measurement of blood pressureby a blood pressure monitor is the sensor of pressure, the signal fromwhich is processed and transformed into a measure of blood pressure (forexample, in mmHg), which later is used for diagnostics and treatment ofmost CVD. But with time, as well as under influence of differentexternal factors such as shock to or dropping of the device, temperaturechanges, ageing of the components, etc, the accuracy of the sensorchanges, which causes errors in measurement. One of the main problems isoften the dropping of the blood pressure monitor, as the main users ofblood pressure monitors are elderly and sick people. That is why bloodpressure measurement devices, whether aneroid, mercury, or electronic,and including all home blood pressure measurement devices, must bechecked regularly for accuracy.

Calibration is performed by attaching the blood pressure monitor to ahighly accurate specialised compressor and checking that the pressuredisplayed by the blood pressure monitor matches that being generated bythe compressor. These compressors are usually maintained by themanufacturers or by specialist companies. The blood pressure monitorsare sent away to the companies for calibration. This is expensive andinconvenient; further, the blood pressure monitor may be dropped ordamaged during transit back from the calibration company, so that theblood pressure monitor is again inaccurate.

Due to these problems, although all consumer blood pressure monitors arecalibrated during manufacture, many are never calibrated again. This ofcourse negatively influences the quality of diagnostics and treatment ofmillions of users of blood pressure monitors.

SUMMARY

The present disclosure is to enable blood pressure monitors to becalibrated in a cheap and convenient manner, particularly by the usersthereof. Accordingly the disclosure provides a blood pressure monitor asdefined in the claims.

Also disclosed is a method for checking or adjusting the calibration ofa blood pressure monitor. The blood pressure monitor includes a pressuresensing means. The method for checking or adjusting the calibration ofthe blood pressure monitor includes the step of taking at least onesealed canister containing a known pressure, connecting the canister influid communication with the pressure sensing means so as to apply theknown pressure to the pressure sensing means, obtaining a reading fromthe pressure sensing means while the canister is in fluid communicationtherewith, and comparing the reading obtained from the pressure sensingmeans with an expected reading so as to check or calibrate the bloodpressure monitor.

Also disclosed is a system that includes: a blood pressure monitorincluding a pressure sensor and at least one port in fluid communicationwith the pressure sensor; and a canister containing a known pressure.The port is arranged to facilitate the connection of a canister so as toplace the gas canister in fluid communication with the port.

In some examples, the gas canister contains a compressed gas at knownpressure. The gas canister may be a disposable single use gas canisterthat includes a seal. The seal being adapted to be ruptured so as toconnect the gas canister with the port substantially without loss ofpressure.

In some implementations, the blood pressure monitor includes aninflatable cuff, which is arranged in use around a part of the user'sbody, and the pressure sensing means is arranged to sense the pressureof gas within the cuff.

The apparatus may be arranged to rupture a seal of the canister onlyafter the adapter is connected to the port. For example, by providingthe rupturing means on the port, and by providing the canister with anengagement portion that is engageable in fluidly sealed manner with theadapter but not with the port. The adapter is engageable in an engagedposition in fluidly sealed manner with the port, and in the engagedposition the rupturing means is arranged to pierce the seal of thecanister. Alternatively, a rupturing means may be provided on theadapter.

The blood pressure monitor includes a shock sensor that records physicaljolts, and an alerting means connected to the shock sensor that alerts auser to indicate that calibration is required when a sufficiently largemechanical shock, or series of shocks, have been recorded.

The blood pressure monitor further includes a timing means, and analerting means connected to the timing means that alerts a user toindicate that calibration is required after a predetermined time periodhas elapsed.

The blood pressure monitor further includes display or output means thatdisplays or outputs a blood pressure reading together with an indicationof a calibration status of the blood pressure monitor.

Also disclosed is a blood pressure monitor that includes a pressuresensing means, a temperature sensing means, and a processor means. Thepressure sensing means is arranged to provide a pressure signal to theprocessor means. The processor means is arranged to process the pressuresignal to provide a pressure reading. In addition, the temperaturesensing means is arranged to provide a temperature signal to theprocessor means. Also, the processor means is arranged to adjust thepressure reading to compensate for the sensed temperature.

DESCRIPTION OF DRAWINGS

An illustrative implementation of the present disclosure will now bedescribed, purely by way of example and without limitation to the scopeof the claims, and with reference to the drawings, in which:

FIG. 1 is a diagrammatic representation of a blood pressure monitor; and

FIG. 2 is a diagrammatic representation of a calibration method andsystem including the blood pressure monitor of FIG. 1 and a disposablecanister.

DETAILED DESCRIPTION

Referring to FIG. 1, a sphygmomanometer or blood pressure monitor 10 isusually used in conjunction with an inflatable cuff 30, which isattached to the monitor 10 by a flexible tube 20. The tube 20 isconnected to the monitor 10 by an attachment valve 12, which leads to achannel 11 which allows fluid communication between the tube 20 and apump 22 and pressure sensor 24. The output of the pressure sensor is fedinto an analogue to digital converter 26, and the resulting digitalsignal is transmitted to a processor (CPU) 28. The CPU 28 controls adisplay 29. The CPU 28 also controls the operation of the pump 22. Inuse, the inflatable cuff is attached to a patient's arm 1, and the userinitiates the monitoring using an input 32, such as a keypad or touchsensitive display, which may be part of the display 29. The pumpsupplies compressed air which increases the pressure in the tube 20 andcuff 30, while the pressure sensor 24 monitors the pressure. The cuff isusually inflated to sufficient pressure to stop the arterial flow in thepatient's arm, and then the pressure in the cuff is released over a timeperiod, during which the arterial flow resumes, and then flowsunimpeded. From the resumption of the arterial flow to unimpeded flow,the pumping action of the heart causes small oscillatory variations inthe cuff pressure. By detecting these small oscillations above and belowthe average pressure by means of the pressure sensor 24, the CPU candetermine when the systolic and diastolic pressures occur, andtherefore, by calculating the underlying average pressure (i.e. removingthe oscillatory variation) determine the systolic and diastolicpressures themselves.

The accuracy of the calculated systolic and diastolic pressures isdependent on the accuracy of pressure measurement by the pressure sensor24. In order to calibrate the pressure sensor, accurately known staticair pressure may be applied in accordance with known art, so that theoutput of the pressure sensor can be checked. This is usually repeatedfor a series of values over the required range of sensitivity. If thereis a difference between the known static air pressure and the reading ofthe pressure sensor, the pressure sensor and/or the processor or othercomponents of the apparatus can be adjusted as necessary until themonitor accurately reflects the applied pressures. This may be done forexample by using the CPU to electronically adjust the pressure sensor,for example, by adjust the gain or other parameters of the internalamplifier of the pressure sensor.

This is usually carried out during the manufacturing process. However,over time, the accuracy of the pressure sensor decreases. This can bedue to physical damage and knocks, the monitor's environment, or simplyuse. After a period of time therefore, the blood pressure monitor musteither be replaced, or recalibrated. Conventionally, recalibration iscarried out in a similar manner to the original calibration duringmanufacture. The blood pressure monitor must be attached (say at lockingvalve 14) to an air compressor which generates a series of known staticair pressures with high accuracy. The pressure sensor's readings canthen be compared with the expected values and the pressure sensoradjusted if necessary. As previously mentioned, this is inconvenient,because such an air compressor is an expensive and specialised piece ofequipment, and usually requires the blood pressure monitor to be sentback to a factory to be recalibrated.

Referring to FIG. 2, a new method of recalibration is shown in relationto the blood pressure monitor 10. A gas canister 16 is provided,containing a volume of air at a known pressure. The blood pressuremonitor is put into calibration mode, the cuff 30 and tube 20 aredisconnected, and a locking nut of the attachment valve 12 is closed.The gas canister 16 is attached to the blood pressure monitor at thelocking valve 14, so that it is in fluid communication with the pressuresensor. The gas canister 16 and the locking valve preferably have aco-operating thread. The locking valve includes a puncture means, sothat the gas canister can be screwed onto the locking valve so as toaccomplish a fluid tight seal. The cap of the gas canister is perforatedat the same time by the puncture means without causing loss of pressureto ambient.

When the gas canister 16 is perforated, the pressurised air from the gascanister is released into the channel 11. The volume of the channel 11may be small relative to the volume of the gas canister, so that thepressure at the pressure sensor 24 is extremely close to the pressure ofthe gas in the gas canister. Alternatively, the volume of the channelcan be taken into account when calibrating the pressure sensor and anallowance made for a known reduction in pressure caused by the expansionof the gas into the volume of the channel.

As well as allowing for the volume of the channel when calibrating thepressure sensor, the blood pressure monitor may include a thermistor orother temperature-measuring sensor. The actual pressure, which will varywith temperature, may then be calculated using this temperature readingby the CPU, and therefore the calibration of the pressure sensor may befurther improved. It should be noted that it is also advantageous toprovide a temperature sensor in a blood pressure monitor independentlyof the calibration method, so that blood pressure readings may beadjusted to account for the ambient temperature.

The release of the gas from the gas canister into the channel may alsoresult in a temperature change of the gas, which will be dependent onthe pressure, the relative volumes of the canister and channel, andpossibly on the type of gas employed. Although the method outlined abovewill allow a sufficiently accurate calibration, if desired, a thermistoror other temperature measuring sensor 41 may be included in the channelto compensate for the pressure variation due to temperature, oralternatively the monitor could be allowed to reach a temperatureequilibrium with the room in which it is used.

While in calibration mode, the CPU of the blood pressure monitor recordsthe constant pressure read by the pressure sensor, and compares thiswith the expected pressure provided by the gas canister. The expectedpressure could be inputted by the user, but is more convenientlypre-programmed in the CPU, so that the user simply has to input anidentifier (ID) printed on the gas canister, which could be for examplea numeral or letter, which is also stored in a memory 36 in associationwith the value of the pressure of the canister. The stored values andidentifiers may be downloaded periodically from a remote database via aUSB connection 39. Even more conveniently, the blood pressure monitorincludes a radio frequency receiver 25 and the gas canister includes anidentifier such as a radio frequency identification (RFID) tag 15. Theradio frequency receiver 25 detects and identifies the gas canister whenit is in sufficiently close proximity (e.g. when it is connected to themonitor), and transmits this to the CPU, which then looks up in memory36 the stored value of the calibration pressure within the canister.

After use, the gas canister is disposed of. Advantageously, the canisteris a disposable single use canister. Since it is not re-usable, eachcanister thus provides an accurately predetermined stored calibrationpressure so that each instance of calibration is carried out with a newcanister that has been filled and sealed in a controlled factoryenvironment.

As in the case of the known calibration technique carried out by themanufacturer, the method shown in FIG. 2 ideally includes calibration byapplying several known pressures to the pressure sensor. Several gascanisters at different precisely known pressures are provided, and eachattached in turn to the blood pressure monitor to check the accuracy ofthe pressure sensor through a range of pressures. If an RF receiver andRFID tags on the gas canisters are employed, the expected pressure foreach reading is supplied by the RF receiver to the CPU.

After the required pressures have been applied to the pressure sensor,the CPU can automatically recalibrate the input received from thepressure sensor so that the blood pressure monitor is correctlycalibrated.

As well as or instead of using a dedicated locking valve 14 on the bloodpressure monitor, a gas canister could be attached utilising the valve12 to which the tube 20 to the cuff 30 is attached, or indeed anysuitable existing port or air jack in fluid communication with thepressure sensor. An adapter 40 could be used to connect the gas canisterand such a port, and the adapter could also include a perforation meansto release the pressurised gas.

Gas from the canister could also be released by establishing a sealedfluid connection to the port in the monitor using some other means thanperforation. The some other means may include, but not limited to, avalve or catch means provided on the top of the canister, which can beopened slightly before, during, or after the canister is fullymechanically attached to the blood pressure monitor, eitherautomatically as part of the fitting process, or by operation by theuser.

The blood pressure monitor includes a timing means, which may include aclock 38 and non-volatile memory 36 that can be written to enable theblood pressure monitor to record the date and time when a calibrationprocedure has been carried out (and if required what gas canisters wereused), and also alert the user when a predetermined time period haselapsed since the last calibration procedure that another calibrationshould be carried out.

Some blood pressure monitors now communicate (using the internet orother wide area networks) with health services providers for automatichome monitoring, for example, via a USB port 39. This is done, and thecalibration status of the blood pressure monitor is also communicated,so that the health services providers can place more confidence inremotely provided readings.

The blood pressure monitor is also provided with an accelerometer orother shock sensor 34 that can sense and record in memory 36 when theblood pressure monitor has been subjected to a shock or jolt; andalerting means (e.g. software incorporated into the CPU) responsive tothe shock sensor, whereby when a sufficiently large mechanical shock, orseries of shocks have occurred, the CPU 28 of the blood pressure monitorcan alert the user (and/or remote monitoring personnel) to indicate (viadisplay 29, USB connection 39, or otherwise) that a calibration isnecessary. It should be noted that it is also advantageous to provide ashock sensor in a blood pressure monitor independently of the abovedescribed method, so that a user can be informed that it is necessary tohave the blood pressure monitor calibrated by conventional calibrationmeans, or to replace the blood pressure monitor.

RFID tags generally include a unique identifier code. This may be usedto check the status of each gas canister. For example, if the bloodpressure monitor is in communication with a health service provider, aremote central database may be checked to ensure that the gas canisterbeing used in the calibration process has not been previously used orthat its useful lifetime has not expired.

It will be realised that this method may also be applied to thecalibration of many different types of blood pressure monitor, includingmanually calibrated blood pressure monitors (and mechanical bloodpressure monitors), and for blood pressure monitors supplied with ahand-operated bulb pump.

The disclosure is particularly advantageous in ensuring accuratecalibration of blood pressure monitors of the type including aninflatable cuff, and in particular, those suitable for monitoring theuser's own blood pressure at home. It may also be used for bloodpressure monitors that do not include an inflatable cuff, for example,those adapted for connection via a catheter to the patient's bloodvessel, in which case the adapter may provide a fluid column and/or amembrane that provides a fluid barrier to transmit pressure between thecanister and the monitor.

The canister 16 may include a closed vessel of any convenient type, suchas a cylinder, vial, ampoule, cartridge, or the like, made for examplefrom metal, glass or plastics material and including a connectionportion adapted to provide both mechanical and sealing fluid connectionto the port of the monitor. The mechanical connection can include ascrew thread, flange, or any other suitable means, and the fluid sealcan be integral with the mechanical connection or can include a surface,gasket, resilient seal, or other element adapted to provide a pressuretight sealed fluid connection to the monitor when the canister ismechanically connected thereto. The canister may provide a frangibleseal such as a thin metal or plastics membrane adapted to be pierced bya penetration means or piercing element of the monitor after connectionthereto. Preferably, the seal is arranged such that the canister may notbe refilled.

The port may be arranged to facilitate the releasable connection of thecuff to the port, in which case the cuff may be connectable directly tothe port or via an adapter that is connectable to the port. The port maybe adapted for connection of the canister directly thereto.Alternatively, the port may be adapted for connection of an adapter tothe port, the adapter being adapted for connection of the canister tothe adapter so as to place the canister in fluid communication with theport.

The valve 14 or other port adapted to receive the canister may beconnected with the cuff by suitable valve means, whereby when thecanister is connected to the valve 14, the cuff is exhausted and/or thevalve 12 is closed and/or the valve 14 is isolated from any pressurewithin the cuff. The valve means may be automatically operable byconnection of the canister to the port, or may preclude the connectionof the canister to the port unless the valve means are first operated toexhaust or isolate the cuff.

The pressure sensor may include a diaphragm with one side in fluidcommunication with the port, and the other side connected to a pressuretransducer. In alternative implementations, rather than applying apositive pressure to a front side of a diaphragm forming part of thepressure sensor which in use experiences the positive pressure withinthe cuff, the novel canister might contain a gas at a negative (relativeto ambient) pressure, i.e. a partial vacuum, or alternatively may becompletely evacuated, and the port may be adapted to apply that negativepressure to a reverse side of the diaphragm whose front side in useexperiences the positive pressure within the cuff; whereby the port forcalibration need not be fluidly connected to the port which communicateswith the cuff in use. In such implementations, valve means may bearranged to exhaust the cuff when the canister is connected to the port,the valve means preferably being operated automatically by connection ofthe canister to the port. In such implementations, referenceshereinbefore to a “gas” are construed mutatis mutandis as including agas at low pressure relative to ambient, and including a vacuum definedby the substantial or complete absence of gas.

It will be understood therefore that the known pressure contained in thecanister is gaseous pressure, which may be the stored pressure of a gasor the negative gauge pressure of a vacuum.

In yet further alternative implementations, rather than connecting thecanister in fluid communication with the diaphragm or other element ofthe fluid sensor that communicates with the cuff in use, it may beconnected in fluid communication with a separate diaphragm, or adiscrete portion of the diaphragm that communicates with the cuff inuse, which separate diaphragm or portion may be for example relativelysmaller than that which receives the gaseous pressure of the cuff, sothat the gaseous pressure in the cylinder may conveniently be relativelyhigher than that applied in use to the cuff.

In yet further implementations, channel 11 provides a relatively large,known volume whereby the canister 16 may contain a relatively smallvolume of (preferably dry) gas at relatively high pressure that expandssubstantially when released into the channel, and the pressure appliedto the pressure sensor is lower than that of the stored gas in thecanister, such that the size of the canister may be convenientlyreduced. A temperature sensor 41 may be provided, whereby the pressuresensing means 24 is arranged to provide a pressure signal to theprocessor means 28. The processor means 28 is arranged to process thepressure signal to provide a pressure reading; and the temperaturesensing means 41 is arranged to provide a temperature signal to theprocessor means, and the processor means is arranged to adjust thepressure reading to compensate for the sensed temperature.Alternatively, the temperature sensor may delay the pressure readinguntil the temperature has risen to a predetermined temperature.

It will be understood that to apply the known pressure within thecanister to the pressure sensor is construed to include to apply theknown pressure as modified by expansion of gas within the canister tothe pressure sensor so as to obtain a known modified pressure (theexpected pressure).

In yet further implementations, stored gas may be used in addition to orinstead of the pump 22 to inflate the cuff. The diastolic and systolicpressures may be calculated as described above or otherwise inaccordance with conventional art. Rather than RFID tags, contact ID tagsor any other identification means may be used.

In yet further implementations, two or more canisters or compartmentswithin a canister may be connected to respective ports simultaneously soas to supply different known pressures simultaneously to differentelements of the pressure sensor, whereby the pressure sensor may providea reading reflecting a differential pressure, e.g. to compensate forambient pressure.

In summary, in a preferred implementation, a blood pressure monitor,particularly of the type having an inflatable cuff communicating with apressure sensor and suitable for home use, may be calibrated by applyinga sealed canister containing gas at a known pressure to a port so as toapply the known pressure to the pressure sensor, and comparing apressure signal from the pressure sensor with the known pressure so asto determine a calibration error of the sensor and/or adjust thecalibration of the sensor, e.g. by electronically adjusting the sensor.Several canisters may be used to calibrate the sensor across a range ofpressures, each canister having a different known pressure. Eachcanister is preferably ruptured when attached to the port and is notre-usable, and may include an identifier such as an electronicallyreadable identifier that is stored in a memory in association with thevalue of the known pressure within the canister. Temperature sensingmeans may be provided whereby the pressure reading is adjusted tocompensate for temperature, e.g. of the gas released from the canister.The monitor includes means for sensing mechanical shock and alerting auser or remote monitoring personnel to provide an indication thatrecalibration is required.

Many other adaptations will be evident to those skilled in the art fromthe foregoing description, and it is to be understood that the scope ofthe disclosure is limited only by the claims.

1-22. (canceled)
 23. A blood pressure monitor including a processorconfigured to carry out a calibration procedure and a blood pressurereading procedure, and further including: a means for recording when thecalibration procedure is carried out, a timing means, a shock sensor,and an alerting means for generating an alert to indicate that a furthercalibration procedure is required after a sufficiently large mechanicalshock or series of shocks has occurred or a predetermined time periodhas elapsed since a previous calibration procedure; wherein the bloodpressure monitor is configured to transmit an indication of acalibration status of the blood pressure monitor together with the bloodpressure reading to a remote location.
 24. A blood pressure monitoraccording to claim 23, wherein the blood pressure monitor is configuredto transmit the alert to the remote location.